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This is a Phase II, single-arm, open-label, multicenter clinical study aimed at evaluating the efficacy and safety of Firmonertinib 160 mg combined with Bevacizumab as neoadjuvant therapy in patients with resectable stage II-IIIB Epidermal Growth Factor Receptor(EGFR)-mutated non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firmonertinib Mesilate Tablets | Drug | Firmonertinib Mesilate Oral administration 160 mg once daily for 3 months before surgery. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment. After surgery, the treatment plan was determined by the researchers, with options including Firmonertinib Mesilate Tablets: Oral administration once daily, 80mg per dose, for 3 years or until disease progression or intolerable toxicity occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| pathological Complete Response(pCR) rate | Defined as the proportion of patients with no residual viable tumor cells in the primary lesion, as assessed by central laboratory pathologists after surgical resection. | Within 24 hours after surgical resection |
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response (MPR) rate | Defined as the proportion of patients with ≤10% viable tumor cells in the primary lesion of the surgically resected specimen as assessed by central laboratory pathologists. | Within 7 days after surgical resection |
| Radical resection rate |
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Inclusion Criteria:
Exclusion Criteria:
Presence of small cell lung cancer or mixed pathological types of NSCLC. EGFR exon 20 insertion mutation detected by genetic testing.
Exposure to any other antitumor therapy prior to enrollment, including perioperative radiotherapy.
The patient is in pregnancy or lactation.
History of other malignant tumors, or currently combined with other malignant tumors (except for malignancies that have undergone radical surgery with no recurrence within 5 years post-operation, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma, etc.).
Presence of severe or uncontrolled systemic diseases requiring treatment, which the investigator deems unsuitable for trial participation, including hypertension, diabetes mellitus, chronic heart failure (New York Heart Association, NYHA Class III-IV), unstable angina, myocardial infarction within the past year, etc.
Severe gastrointestinal dysfunction, diseases, or clinical conditions that may affect the intake, transport, or absorption of the study drug, such as inability to take oral medications, uncontrollable nausea and vomiting, extensive gastrointestinal resection history, etc.
Any of the following laboratory tests indicate insufficient bone marrow reserve or organ reserve function.
Known or suspected allergy to almonertinib mesylate, bevacizumab, or any other component of their formulations, or patients with other contraindications.
If the patient cannot comply with the study procedures, restrictions, and requirements, or if the investigator deems the patient ineligible or unsuitable for participation in the study for any other reason.
Patients currently or previously enrolled in any other anti-tumor clinical studies.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Wanpu Associate Consultant | Contact | +86 01088196103 | yanwanpu@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | China |
Not applicable. No individual participant data will be made available. Aggregate results will be reported in publications and on ClinicalTrials.gov; general inquiries may be directed to the corresponding author, but IPD will not be shared.
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Study participants will receive oral Firmonertinib 160 mg once daily for 3 months before surgery, and Bevacizumab injection administered every 21 days as one cycle, for a total of 2 cycles. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment. The investigator will determine the postoperative adjuvant treatment regimen, with options including Firmonertinib Mesilate Tablets: Oral administration once daily, 80mg per dose, for 3 years or until disease progression or intolerable toxicity occurs.
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|
| Bevacizumab injection | Drug | Bevacizumab injection (intravenous infusion, 7.5 mg/kg) administered every 21 days as one cycle, for a total of 2 cycles. Radical tumor resection will be performed at least 6 weeks after completion of Bevacizumab treatment. |
|
Defined as the proportion of patients who successfully underwent R0 resection among enrolled patients |
| Within 7 days after surgical resection |
| Lymph node downstaging rate | Defined as the proportion of patients whose lymph node staging was downgraded after neoadjuvant therapy and surgical treatment, as confirmed by pathological assessment. | Within 7 days after completion of neoadjuvant therapy and within 7 days after surgical resection |
| Pathological positive lymph node conversion rate | Defined as the proportion of pathologically positive lymph nodes that convert to negative after neoadjuvant therapy, as assessed by pathologists. | Within 7 days after completion of neoadjuvant therapy and within 7 days after surgical resection |
| Objective response rate (ORR) by investigator | Defined as the proportion of patients who achieved complete response or partial response after 9 weeks following the first dose of Firmonertinib, as assessed by investigator using Computed Tomography (CT) scans according to RECIST 1.1 criteria. | Approximately 9 weeks following the first dose of Firmonertinib |
| Event-free survival (EFS) | Defined as the time from the first administration of study treatment to the occurrence of an event or death, whichever occurs first. Events include documented disease progression that prevents surgery or necessitates non-protocol-specified treatment; local or distant disease recurrence or new lesions (pathologically confirmed new primary malignancies are not considered EFS events). | From first dose until the event of interest, assessed up to 36 months after the first dose |
| Safety: Occurrence and frequency of adverse events, severity, surgical complications | Occurrence and frequency of adverse events, severity, surgical complications | From randomization to 30 days after treatment completion |
| Patient-reported outcomes: Change from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30) | Assessed using EORTC QLQ-C30 to evaluate patient symptoms and overall quality of life. Unit of Measure: Score on a 0-100 scale Range: 0 = Worst; 100 = Best (Higher score indicates better quality of life) | Day1/21/42/63/84 of Neoadjuvant Therapy |
| Patient-reported outcomes: Change from European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13(QLQ-LC13) | Assessed using EORTC QLQ-LC13 to evaluate patient symptoms and overall quality of life. Unit of Measure: Score on a 0-100 scale Range: 0 = Worst; 100 = Best (Higher score indicates better quality of life) | Day1/21/42/63/84 of Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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